ABSTRACTThe optimal duration of oral nucleos(t)ide analogue therapy for HBeAg negative chronic hepatitis B (CHB) has not been defined. The aim of this study was to investigate the clinical efficacy of 24-months course of lamivudine therapy in patients with HBeAg negative CHB in Korea. A total of 50 Korean patients with HBeAg negative CHB were prospectively enrolled. The patients received 100 mg/day of lamivudine orally for 24 months. Patients who showed complete response at 24 months to lamivudine therapy stopped treatment, and regular follow-up was done thereafter. The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months. The complete response rate at months 12 and 24 were 86.0% (43/50) and 86.0% (43/50), respectively, and the clinical breakthrough at months 12 and 24 were 4.0% (2/50) and 14.0% (7/50), respectively. The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively. In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

Mentions:
The 43 patients who showed complete response without evidence of clinical breakthrough at 24 months of lamivudine therapy were removed from treatment and regular follow-up was done thereafter. In these patients, the mean duration of follow-up after cessation of lamivudine therapy was 40.8±22.7 (range 12-96) months. The number of patients at follow up months 12, 24, 36, 48, and 60 were 33, 18, 14, 8, and 5, respectively. The expected durability of response after cessation of 24 months-course lamivudine therapy was calculated by the Kaplan-Meier method, and the results at months 12, 24, 36, 48, and 60 of follow-up were 79.1%, 64.0%, 56.9%, 47.4%, and 47.4%, respectively (Fig. 2). There were no episodes of hepatic decompensation in relapsed patients after withdrawal of lamivudine. When comparing the characteristics of those who have relapsed and those who have not relapsed, the proportion of liver cirrhosis patients was significantly higher in relapsers than non-relapsers (44% vs. 16%, P=0.040). Meanwhile, there was no difference in age, sex, baseline ALT level, previous interferon treatment history, family history of hepatitis B, or the follow-up duration after cessation of lamivudine therapy between the two groups (Table 2).

Mentions:
The 43 patients who showed complete response without evidence of clinical breakthrough at 24 months of lamivudine therapy were removed from treatment and regular follow-up was done thereafter. In these patients, the mean duration of follow-up after cessation of lamivudine therapy was 40.8±22.7 (range 12-96) months. The number of patients at follow up months 12, 24, 36, 48, and 60 were 33, 18, 14, 8, and 5, respectively. The expected durability of response after cessation of 24 months-course lamivudine therapy was calculated by the Kaplan-Meier method, and the results at months 12, 24, 36, 48, and 60 of follow-up were 79.1%, 64.0%, 56.9%, 47.4%, and 47.4%, respectively (Fig. 2). There were no episodes of hepatic decompensation in relapsed patients after withdrawal of lamivudine. When comparing the characteristics of those who have relapsed and those who have not relapsed, the proportion of liver cirrhosis patients was significantly higher in relapsers than non-relapsers (44% vs. 16%, P=0.040). Meanwhile, there was no difference in age, sex, baseline ALT level, previous interferon treatment history, family history of hepatitis B, or the follow-up duration after cessation of lamivudine therapy between the two groups (Table 2).

Bottom Line:
The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months.The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively.In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.

ABSTRACTThe optimal duration of oral nucleos(t)ide analogue therapy for HBeAg negative chronic hepatitis B (CHB) has not been defined. The aim of this study was to investigate the clinical efficacy of 24-months course of lamivudine therapy in patients with HBeAg negative CHB in Korea. A total of 50 Korean patients with HBeAg negative CHB were prospectively enrolled. The patients received 100 mg/day of lamivudine orally for 24 months. Patients who showed complete response at 24 months to lamivudine therapy stopped treatment, and regular follow-up was done thereafter. The mean follow-up duration after cessation of therapy was 40.8+/-22.7 (range 12-96) months. The complete response rate at months 12 and 24 were 86.0% (43/50) and 86.0% (43/50), respectively, and the clinical breakthrough at months 12 and 24 were 4.0% (2/50) and 14.0% (7/50), respectively. The expected durability of responses at months 12, 24, and 36 after cessation of lamivudine therapy in 43 complete responders was 79.1%, 64.0%, and 56.9%, respectively. In conclusion, a 24-months course of lamivudine therapy shows high end-treatment response rate and substantial durability of initial response after cessation of therapy in HBeAg negative CHB patients in Korea.